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510(k) Data Aggregation
K Number
K201683Device Name
PMMA Block
Manufacturer
Huge Dental Material Co., Ltd.
Date Cleared
2020-11-03
(134 days)
Product Code
EBG, EBI, MQC
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Huge Dental Material Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.
Indications for Use:
- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Implant surgical guide;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
Device Description
PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.
PMMA BLOCK are made with the same material (Hot cured PMMA) that is used for the manufacture of the HUGE Synthetic Polymer Teeth (K101029) and HUGE PMMA Block(K141421). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This guarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.
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K Number
K101029Device Name
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
Manufacturer
HUGE DENTAL MATERIAL CO., LTD.
Date Cleared
2010-08-16
(125 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
HUGE DENTAL MATERIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
Device Description
The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent.
Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
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